Abbott has conducted a voluntary recall of three lots of POWERSAIL® Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints (one from each lot) that the distal shaft of the catheter exhibited damage.

While the issue could be detected and avoided during the preparation for use of the product, it may cause a leak of contrast material during use, which could lead to catheter functional failures and clinical consequences, including air embolism and myocardial infarction, which has the potential to lead to death.

Abbott Vascular’s sales representatives contacted all customers affected by this action and instructed them to cease use of any units from the part numbers and lot numbers listed below. All outstanding units are in the company’s possession or are in transit. Patients who have already been treated are not affected by this action.

The United States Food and Drug Administration (FDA) has been apprised of this action, and it has classified this action as a Class I recall.

The POWERSAIL Coronary Dilatation Catheter is distributed for prescription use only to approved U.S. and international health care organizations. Affected devices can be identified by the part number and lot number combinations shown above.

Customers with questions or concerns should contact their Abbott Vascular Representative or call the company at 1-800-227-9902.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program.

FDA 07/30/09

Teva Pharmaceuticals USA is initiating a voluntary recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B. The product lots identified are being recalled due to the presence of elevated endotoxin levels in some vials within these lot numbers.

Teva has been notified of 41 propofol-treated patients who experienced post-operative fever, chills and other flu-like symptoms. Based on available information it appears that all febrile or flu-like reactions were self-limiting with spontaneous resolution.

Adverse health effects, such as fever, chills, or rigors, are possible with exposure to product with elevated levels of endotoxins. Serious adverse effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock, and death, are possible with exposure to product with high endotoxin levels.

For use as an anesthetic agent, propofol should be used only by professionals trained in the administration of general anesthesia. For sedation of intubated, mechanically ventilated patients in the Intensive Care Unit, propofol should be administered only by persons skilled in the management of critically ill patients.

Customers who have Propofol lots 31305429B and 31305430B in their possession are instructed to cease using the product and return it to their distributor.

Teva Pharmaceuticals USA is voluntarily recalling the aforementioned lots. The FDA and CDC have been apprised of this action. Consumers with questions may contact 1-866-262-1243.

Any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Program by phone at 1-800 FDA-1088; by fax at 1-800-FDA-0178; by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

FDA 07/16/09